Financial Conflict of Interest

Trainee Monitoring Guideline

BUMC/CRC Advisory Committee on Investigators'Conflicts of Interest Committee Guidelines for Monitoring the Involvement of Trainees in Research Affected by Conflicts of Interest
Approved by BUMC and CRC Advisory Committees on Investigators'Conflicts of Interest September, 2005

Applicability

This guideline will generally be followed by monitors who are appointed by the BUMC or CRC Advisory Committee on Investigator's Conflicts of Interest. However, the Committee may, in any specific decision, modify or amplify the responsibilities of monitors and individuals with a conflict of interest as appropriate to the case. This guideline is subject to the provisions of applicable laws, regulations and institutional policies.

Committee

The Committee may appoint a member of the Committee, or request the Provost to appoint another faculty member to monitor any situation in which trainees (post docs or students) are involved in research that could be affected by a conflict of interest.

The monitor should be a faculty member, who is outside of the research study and is not a subordinate of the Principal Investigator. Furthermore, the monitor is an individual whom the trainee(s) would feel comfortable coming to and who is not in a position to oversee the student's work or to take any adverse action against the student.  The monitor's role is to be an advocate for the trainee's interests.

Monitor

Criteria for Monitoring: The monitor will be responsible, unless otherwise indicated by the Committee, for:

  1. initiating contact with  the trainee
  2. if possible, speaking with the trainee; otherwise using e-mail
  3. confirming that the trainee has received a Dear Colleague letter
  4. offering the trainee an opportunity to meet, answer any questions, and speak about any concerns, at any  time
  5. providing the trainee in writing with the contact information of the monitor
  6. informing the trainee that the monitor will initiate contact again with the trainee in one year's time, and that s/he will be available at any time to address trainee's concerns

In addition, if the trainee is a degree candidate, the monitor will, generally, be responsible for

working with the dissertation committee chair and addressing the conflict situation

Individual with a Conflict of Interest

The individual with the conflict of interest will be expected to provide the monitor with all necessary contacts and related information.

Monitor's reporting

The minimum frequency of monitoring contacts will be recommended by the Committee as warranted by the circumstances.

The monitor will report to the Committee after the initial monitoring contact, any other significant contact, and any visit to a dissertation committee.  These events will be reported on by brief e-mail messages to the Conflict of Interest Committee Coordinator, who will place the item on the next agenda for verbal report.
           
These reports should note that monitoring has been done, and, if any concerns arise, these should be brought to the attention of the Committee.  Concerns could include, for example,

  • a trainee's report that he or she feels that bias is negatively affecting his/or her academic program due to the conflict of interest or
  • the monitor's assessment that the academic  program or independence of the trainee appears to have been compromised by the effects of the conflict of interest, and the reasons for that assessment.